Events

Recall of Premier Care Recliner Model 5570

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Winco Mfg., LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61049
  • Event Risk Class
    Class 2
  • Event Number
    Z-1106-2012
  • Event Initiated Date
    2011-10-17
  • Event Date Posted
    2012-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107176
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Chair, with casters - Product Code INM
  • Reason
    On 10/17/2011 winco mfg. llc, ocala, fl initiated a recall of the premier lifecare recliner and premier care recliner models 5400 and 5570 distributed between january 4, 2011 and october 12, 2011. the position lock pin(s) could potentially fail if exposed to excessive force when the chair is in the locked recline position. this failure will result in an inoperable position lock bar feature.
  • Action
    Winco Mfg. sent a "POSITION LOCK PIN RECALL NOTIFICATION" letter dated October 24 , 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an enclosed response form and provide product disposition. Winco will ship retro-fit parts to install on the affected product. Instructions will explain step by step, how to implement the fix. Contact Winco at 800-237-3377 for questions regarding this recall.

Device

Premier Care Recliner Model 5570
  • Model / Serial
    Model 5570
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, KS, MA, MI, MO, MS, NC, NM, NY, OK, PA, SC, SD, TN, TX, VA, WI, and the country of Canada.
  • Product Description
    Premier Care Recliner Model 5570. || Brochure: "***Premier Care Recliner 5570/5574***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Multiple side-table options***3-position lock-bar*** Fully upholstered***OPTIONAL Heat or Heat & Massage***OPTIONAL LiquiCell***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA.***" || Press on type label: "***Manufactured By Winco Ocala, FL 34474***Model No. 557***Serial No. 557-...***" || Press on type label: "***Model No. 557***Serial No.557-...***". || Long-term multi-positional recliner.
  • Manufacturer
    Winco Mfg., LLC

Manufacturer

Winco Mfg., LLC
  • Manufacturer Address
    Winco Mfg., LLC, 5516 SW 1st Ln, Ocala FL 34474-9307
  • Manufacturer Parent Company (2017)
    Winco Mfg. Llc
  • Source
    USFDA